Kornimate/medical-research-clean huggingface dataset:
therapeutic monitoring of vancomycin in critical ill patients: a registry

Conditions: Critically Ill

Summary: vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant staphylococcus aureus (mrsa). its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. so far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using ppk and bayesian methods based on observed concentrations. the objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant staphylococcus aureus (mrsa). vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. moreover, the chinese vancomycin tdm guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(ppk) and bayesian methods. however, there is a gap between clinical practice and the guideline. so far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using ppk and bayesian methods. pharmacists could provide the vancomycin individualized dosing service by joining the icu multidisciplinary team. the objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists. this is a single-center, ambispective cohort study. patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. the exposure is whether patients received pharmacists' consultation. patients who meet the inclusion and exclusion criteria will be included in our registry. as a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.

Eligibility criteria:
inclusion criteria: * admitted to intensive care unit(icu), peking university third hospital since jan 2010. * receiving vancomycin therapy for 72 hours or more. * aged ≥ 18 years. exclusion criteria: * administration of vancomycin in non-intravenous access. * life expectancy of less than 24 hours. * pregnancy women. * presence of immunodeficiency. * presence of hematological disorder. * written informed consent not obtained in the prospective cohort.

Keywords: vancomycin critically ill pharmacist population pharmacokinetic bayesian methods
diagnostic markers of neuropathic odontalgia

Conditions: Oral Mucosa

Summary: the diamond study aims to investigate the presence and diagnostic relevance of potential biomarkers of the blood-nerve barrier disruption as surrogate markers of painful post-traumatic trigeminal neuropathic pain in patients presenting with neuropathic odontalgia. the first part of the study explores the proof-of-concept and technical feasibility of intra-epithelial nerve fiber immunostaining in gingival/oral mucosa biopsies and the potential presence of these biomarkers in healthy patients (baseline condition).

painful post-traumatic trigeminal neuropathy (ppttn) defines a neuropathic painful condition affecting the orofacial region, following local nerve trauma, usually secondary to dental treatments (tooth avulsion, root canal treatments....). it often presents as odontalgia of atypical presentation, unresponsive to conventional treatments. the diagnostic is often complex (and often is a diagnosis of elimination), leading to unnecessary iatrogenic dental treatments and insufficient pain relief. this study aims to explore potential new markers of ppttn, based on a translational approach following previous preclinical work that showed the importance of the disruption of the blood-nerve barrier in generating post-traumatic neuropathic pain. several markers of such disruption have been highlighted (such as claudin-5, patched-1 and frizzled-7) that could be specifically downregulated in neuropathic pain conditions (as compared to inflammatory neuritis conditions). as such, these markers could be interesting biomarkers of neuropathic pain. this study aims to explore the presence (and absence) of such markers in healthy vs neuropathic patients respectively. the first part of the study investigates the technical feasibility of intra-epithelial nerve fiber staining in oral mucosa/gingiva specimens collected in healthy patients (undergoing routine oral surgery procedures) and the immunoreactivity/presence of such biomarkers in those specimens.

Eligibility criteria:
inclusion criteria: adult patients (over 18 years old) requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure) exclusion criteria: * patient with a diagnosed odontalgia * patient with painful post-traumatic trigeminal neuropathy (ppttn) * patient with unexplained pains or a neuropathic pain regardless of its location * patient under guardianship or trusteeship * patient who refuses to give his/her non-opposition to participate to the study

Keywords: painful post-traumatic trigeminal neuropathy neuropathic pain neuropathic odontalgia gingival biopsy
a study designed to test the effectiveness and safety of treating patients with lacosamide for migraine prophylaxis

Conditions: Migraine

Summary: the purpose of this study is to see how safe and effective lacosamide (lcm) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.

this study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).

Eligibility criteria:
inclusion criteria: * history of migraines headaches for 1 year and well documented 3 month retrospective history of migraines. * experience 2-8 migraines per month but not more than 15 headache days per month. there should be at least 48 hours of freedom between headaches. * on effective stable abortive medication(s) for the acute treatment of migraine. exclusion criteria: * subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial. * use of triptans or ergots for migraine abortive treatment \> 2-3 days per calendar week 2 months prior to screening. * experience 15 or more headache days per month of any kind 2 months prior to screening. * has another consistent or chronic form of headache. * unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring. * pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial. * significant laboratory or electrocardiograms (ecg) abnormalities * significant medical history including cardiovascular abnormalities.

Keywords: lacosamide migraine prophylaxis vimpat
acupuncture for elevated intraocular pressure

Conditions: Elevated Intraocular Pressure

Summary: glaucoma is the leading cause of irreversible blindness in the world, resulting from progressive axonal destruction of the optic nerve. primary open-angle glaucoma is the most common form, and it is usually painless with insidious onset. conventional treatment is focused on lowering intraocular pressure (iop), the one risk factor that can be modified, which has been demonstrated to protect against further damage to the optic-nerve head. acupuncture is an ancient treatment which has been found to be beneficial for many ailments, and may reduce iop. we propose a pilot study to evaluate whether acupuncture is an effective and safe modality for reducing elevated iop in patients with open angle glaucoma and primary ocular hypertension. patients with elevated iop on tonometric measurement (20mmhg \< iop \< 30mmhg) will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment. treatment will last for four-weeks (for a total of 8 treatments), and patients will be evaluated for iop diurnal curves at 2 weeks (4 treatment), 4 weeks (end of treatment ) and then 4 weeks following the last treatment.


Eligibility criteria:
inclusion criteria: patients of either gender; age 21 years and older; intraocular pressure equal/greater than 20mmhg, equal/less than 30mmhg; ability to comply with study protocol exclusion criteria: patients with secondary or closed-angle glaucoma; patients with a history of laser or other surgical treatment of glaucoma; patients displaying symptoms of depression, anxiety or psychosis

Keywords: acupuncture, intraocular pressure, glaucoma
use of the equimolar mixture of oxide nitrous and oxygen (emono) associated with audiovisuals in children

Conditions: Pain, Acute; Child, Only; Nurse's Role; Nitrous Oxide

Summary: children experience numerous painful experiences from nursing procedures: peripheral venous access placement is the main cause of procedural pain. as much as pharmacological and nonpharmacological tools are known, their application during venipuncture is not systematic by children's hospitals. among pharmacological tools, the equimolar mixture of nitrogen protoxide and oxygen (emono) provides adequate protection from procedural pain through inhalation of the gas mixture at least 3 minutes before the procedure. literature reports that the combination of nonpharmacological distractive tools and pharmacological interventions increases their analgesic effect. the aim of the study is to measure children's cooperation during procedure (primary outcome), pain perception and side effects when emono is combined with audiovisuals compared with emono alone in peripheral venous access placement.


Eligibility criteria:
inclusion criteria: * age between 2 years and 5 years and 364 days * prescription for peripheral venous access placement * parental consent for participation in the study * presence of at least one parent in possession of a smartphone/tablet with the ability to connect to the internet through wi-fi available to users * absence of contraindications to the administration of emono reported in health records * absence of facial pathology * presence on duty of at least one experimental nurse trained in the use of emono exclusion criteria: * age less than 2 years and more than 5 years and 364 days * no parental consent to participate in the study * parents not in possession of a smartphone/tablet with the ability to connect to the internet through wi-fi available to users * presence of contraindications to emono administration * presence of facial pathology * oxygen therapy * presence of tracheostomy * absence on duty of at least one experimental nurse trained in the use of emono
diagnostic biomarkers exploration of breast cancer from serum and urine

Conditions: Breast Neoplasm Female

Summary: the goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. the main questions it aims to answer are: * compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population. * construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients. participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. when necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.


Eligibility criteria:
inclusion criteria: 1. signing the consent of informedness; 2. patients with breast mass who need surgery after examination; 3. cardiac ultrasound indicates that the blood score of the heart is within the normal range; 4. ecog≤0-2 points; 5. oversure function is acceptable. exclusion criteria: 1. merge other malignant tumors such as gynecologic oncology; 2. after evaluation, the internal organs are not suitable.

Keywords: serum and urine biomarkers,machine learning,diagnostic model
summertime: kids in motion

Conditions: Sleep

Summary: this is a 3-week randomized crossover study to determine the effect of the prior night's sleep duration on energy-balance related behaviors of diet and physical activity the following day. in week 1, child participants will sleep their usual amount. in week 2, participants will be randomized to either a sleep restricted or a healthy sleep condition for 4 nights. in week 3, participants will cross over to the opposite sleep condition for 4 nights.

individuals of mexican descent comprise the largest proportion of the latino population in the united states and they suffer high rates of obesity. short sleep is a risk factor for obesity. an improved understanding of the underlying behavioral mechanisms by which short sleep duration may impact obesity among mexican american children is critical to prevent and/or reduce obesity and chronic disease in this population. this research will focus on behavioral mechanisms (i.e., diet and physical activity) that link sleep duration to obesity. mexican american 8-10-year-olds will participate in a 3-week crossover study to examine: 1) contextual factors (i.e., bedtime routines, sleep hygiene, familism) that may impact sleep; and 2) the impact of prior night's sleep duration on diet and physical activity the subsequent day. this research design will make it possible to examine whether sufficient sleep is protective of energy balance (e.g., healthful dietary intake/patterns and physical activity) as well as contextual factors related sleep.

Eligibility criteria:
inclusion criteria: * mexican american child-mother pairs which will include: child 8-10 years old; mother/female guardian; english/spanish speakers; mobile phone user. exclusion criteria: * children with major illnesses and/or with sleep apnea for which children * in families where 2 children are eligible for participation, a child will be selected at random to participate in the study. * the investigators will exclude fathers from this study for reasons due to statistical power
a study to evaluate inca035784 in participants with myeloproliferative neoplasms

Conditions: Myeloproliferative Neoplasms

Summary: this study is being conducted to evaluate the safety and tolerability of inca035784 in participants with myeloproliferative neoplasms.


Eligibility criteria:
inclusion criteria: * age 18 years or older at the time of signing the icf * ecog performance status of 0 to 1 for the dose escalation (part 1a) and 0 to 2 for the dose expansion (part 1b) * documented calr exon-9 mutation * confirmed diagnosis of mpn according to the 2022 icc criteria: * dipss+ intermediate-2/high-risk mf with prior jaki, \<20% blasts, and measurable spleen * high-risk et with platelets \>450×10⁹/l * resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for mf and ≥2 prior lines for et * no prior stem cell transplant and none planned within 6 months * minimum laboratory requirements: * platelet count ≥50 × 10⁹/l * absolute neutrophil count ≥1 × 10⁹/l * international normalized ratio (inr) and activated partial thromboplastin time (aptt) ≤1.5 × upper limit of normal (uln), unless receiving vitamin k antagonists * alanine aminotransferase (alt) and aspartate aminotransferase (ast) \<2.5 × uln * total bilirubin \<2 × uln * estimated creatinine clearance \>45 or \>30 ml/min (depending on study part) exclusion criteria: * major bleeding or thrombosis (e.g., stroke, dvt, pe) within the past 3 months * active or high-risk hbv, hcv, or hiv infection, or other chronic active infections requiring systemic treatment * active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer) * pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myeloproliferative neoplasms myelofibrosis essential thrombocythemia calr mutation
clinical study assessing idrabiotaparinux sodium injections once-weekly in pulmonary embolism therapeutic approach

Conditions: Embolism; Thrombosis

Summary: objectives are to evaluate whether idrabiotaparinux sodium (ssr126517e) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (vte) in patients with symptomatic pulmonary embolism (pe) with or without symptomatic deep venous thrombosis (dvt) and to assess its safety (bleedings) versus warfarin.

treatment with a therapeutic dose of any low molecular weight heparin (lmwh) or unfractioned heparin (ufh) or fondaparinux is allowed only within the 36 hours immediately preceding randomization. randomization is performed as soon as the diagnosis of pe (and dvt if concomitant suspected symptomatic dvt) is confirmed. allocation to treatment is done centrally by interactive voice response system (ivrs) and stratified by (1) center, (2) intended treatment duration, ie, 3 months or 6 months. at randomization, the planned duration of treatment (3 or 6 months) is prespecified by the investigator and determined on the assessment of risk of vte recurrence. participants are randomized to either idrabiotaparinux + placebo of warfarin, or warfarin + placebo of idrabiotaparinux, with an initial treatment of at least 5 days with enoxaparin in both treatment groups. participants in the 3-month stratum have an additional 13-week observational period after cessation of study treatment. participants in the 6-month stratum have a 13-week up to 26-week observational period.

Eligibility criteria:
inclusion criteria: * symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis exclusion criteria: * end stage renal failure, hepatic failure, uncontrolled hypertension; * active bleeding or high risk for bleeding; * pregnancy or childbearing potential without proper contraceptive measures, threatened abortion. * breastfeeding. * known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins; * hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin; * indication of prolonged anticoagulation therapy for other reason than pe; * life expectancy \< 6 months;

Keywords: deep venous thrombosis pulmonary embolism anticoagulant drugs
vnotes and vaginal hysterectomy for benign indications

Conditions: Hysterectomy; Hysterectomy, Benign Uterine Diseases; Hysterectomy, Vaginal

Summary: this study aimed to compare the surgical outcomes of vaginal natural orifice transluminal endoscopic surgery (vnotes) and conventional vaginal hysterectomy (vh) for benign gynecological conditions. a prospective analysis will conducted at a tertiary hospital from january 2025 to february 2025. patients aged 40-80 who underwent hysterectomy for benign indications will included. outcomes will assessed included surgical outcomes, visual analog scale (vas) pain scores, and complication rates.


Eligibility criteria:
inclusion criteria: * aged between 40 and 80 years * undergo hysterectomy for benign gynecological conditions exclusion criteria: * history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures), * suspected gynecologic malignancies, * endometriosis, * tubal-ovarian abscesses, * pelvic organ prolapse exceeding grade 2, * individuals who refused to participate in the study

Keywords: vnotes vaginal hysterectomy benign gynecology surgical outcomes pain
sodium nitrite in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to determine whether the intravenous infusion of sodium nitrite safely prevents ischemia-reperfusion injury in subjects with acute myocardial infarction resulting in improved left ventricular function.

despite reperfusion therapies, significant myocardial injury continues to occur from ischemic-reperfusion injury. studies in animal models of acute myocardial infarction suggest that an infusion of sodium nitrite, which is nonenzymatically converted to nitric oxide in the setting of ischemia, significantly reduces ischemia-reperfusion injury resulting in smaller infarcts and improved left ventricular function. the objectives of this phase 2 trial are to determine the tolerability and safety of a 48-hour infusion of sodium nitrite in patients with an acute st-segment elevation myocardial infarction receiving percutaneous coronary intervention. the efficacy of a 48-hour infusion of sodium nitrite will be determined by noninvasive imaging to determine infarct size and left ventricular function.

Eligibility criteria:
inclusion criteria: * acute st segment elevation myocardial infarction * eligible for percutaneous coronary intervention exclusion criteria: * cardiogenic shock * cardiac arrest * prior infarct in the infarct related artery * hemoglobinopathy, glucose-6 phosphate dehydrogenase (g6pd) deficiency

Keywords: acute myocardial infarction reperfusion injury nitric oxide
impact intervention for children with asd

Conditions: Autism Spectrum Disorder

Summary: this randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of preschoolers with autism spectrum disorder (asd). the children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and several weeks after its conclusion (follow-up).

previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (asd). the aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. more specifically, the investigators will assess the effect of project impact, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children. the intervention is suitable for preschoolers with a diagnosis of asd and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in flanders. children with a diagnosis of asd (or children who are suspected of asd) between 1,5 and 4 years old and their parents will participate in the study. they will be randomly assigned to the impact intervention or treatment as usual. the investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities. the families will be invited to come to the faculty of psychology and pedagogical sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 18 weeks) and 12 weeks after the end of the intervention.

Eligibility criteria:
inclusion criteria: * a clinical or working diagnosis of asd exclusion criteria: -